INDIANAPOLIS, June 1, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ: INCY) will present
data from post-hoc analyses that suggested OLUMIANT®
(baricitinib) 4 mg tablet reduced pain and duration of morning
joint stiffness, and improved overall physical function at 12
weeks, among patients with moderate to severe rheumatoid arthritis
(RA), compared to HUMIRA® (adalimumab) and placebo.
These results are being presented at the virtual Annual European
Congress of Rheumatology (EULAR), June 2-5,
2021.
In a post-hoc analysis of the Phase 3 RA-BEAM study, patients
treated with OLUMIANT 4 mg saw greater improvements in pain relief
and physical function, as well as reduced duration of morning joint
stiffness, at 12 weeks compared to HUMIRA and placebo. These
differences in pain relief were not influenced by disease activity
during treatment. In this analysis, improvements in fatigue with
OLUMIANT 4 mg were greater than with placebo and similar to HUMIRA
after 12 weeks of treatment. Safety results were consistent with
the established safety profile for OLUMIANT in patients with RA.
For methodology, see the "About the Analysis" section below.
Patient-Reported
Outcomes at week 12
|
Remission
(Clinical Disease Activity Index [CDAI]=2.8)
|
Low Disease
Activity (CDAI=10)
|
Moderate Disease
Activity (CDAI=22)
|
PBO
|
ADA
|
BARI
4 mg
|
PBO
|
ADA
|
BARI
4 mg
|
PBO
|
ADA
|
BARI
4 mg
|
Change in Pain, as
measured by Pain Visual Analog Scale (Pain VAS)
|
-28.4
|
-37.9
|
-40.9
|
-24.5
|
-32.6
|
-36.1
|
-18.0
|
-23.7
|
-28.1
|
Change in Health
Assessment Questionnaire-Disability Index (HAQ-DI)
|
-0.6
|
-0.7
|
-0.9
|
-0.5
|
-0.7
|
-0.7
|
-0.4
|
-0.5
|
-0.6
|
Change in Duration
of Morning Joint Stiffness (min)
|
-6.9
|
-37.8
|
-64.9
|
-6.3
|
-35.3
|
-55.7
|
-5.3
|
-31.3
|
-40.2
|
Change in
Functional Assessment of Chronic Illness Therapy-Fatigue
(FACIT-F)
|
9.8
|
11.8
|
11.1
|
8.8
|
10.6
|
10.2
|
7.0
|
8.7
|
8.7
|
"Despite available treatment options, patients with rheumatoid
arthritis are still living with daily symptoms, including pain,
that continue to limit their day-to-day activities," said Professor
Peter C. Taylor, Professor of
Musculoskeletal Sciences at the University of
Oxford, and lead author of this analysis. "This analysis
offers valuable insights to rheumatologists seeking to help their
patients reduce disease activity and address the symptoms that are
important to patients."
Lilly will also present analyses from the prospective Swiss
Clinical Quality Management (SCQM) observational cohort, a study
that evaluated the effectiveness and persistence of OLUMIANT
compared to other biologics for the treatment of RA.
OLUMIANT is an oral JAK inhibitor discovered by Incyte and
licensed to Lilly. OLUMIANT is approved and commercially available
in more than 75 countries as a treatment for adults with moderately
to severely active RA, and in more than 40 countries, including the
European Union and Japan, for the
treatment of adult patients with moderate to severe atopic
dermatitis who are candidates for systemic therapy. OLUMIANT was
recently approved in Japan for the
treatment of pneumonia associated with COVID-19 in hospitalized
adult patients.
About The Analysis
- Baricitinib Provides Greater Improvements in
Patient-Reported Outcomes Across All Disease Activity Levels
Compared to Placebo and Adalimumab in Rheumatoid Arthritis
-
- In a post-hoc analysis, 1,305 patients from the Phase 3 RA-BEAM
study were randomized into one of three treatment groups: oral,
once-daily, OLUMIANT 4 mg on background methotrexate, injectable
every-other-week adalimumab 40 mg on background methotrexate and
placebo on background methotrexate.
- Pain was evaluated using a 0-100 mm visual analog scale, with
higher scores indicating more pain; physical function was assessed
using the HAQ-DI, with lower scores indicating better physical
function and, thus, less disability; duration of morning joint
stiffness (minutes) was reported by the patient, and fatigue was
measured using the FACIT-F scale, with higher scores indicating
less fatigue. Disease activity was measured using the CDAI and
categorized as remission (REM, ≤2.8), low disease activity (LDA,
>2.8 to ≤10), moderate disease activity (MDA, >10 to ≤22), or
high disease activity (HDA, >22).
- Linear regression was used to model the relationship between
change in patient reported outcomes at Week 12 (response) and CDAI
values at 12 weeks (primary explanatory variable) to evaluate the
extent of improvement in patient-reported outcomes with OLUMIANT 4
mg relative to placebo and adalimumab across a spectrum of disease
activity levels. Last observation carried forward was used to
impute missing values.
Indication and Usage for OLUMIANT (baricitinib) tablets (in
the United States) for RA
patients
OLUMIANT® (baricitinib) 2 mg is
indicated for the treatment of adult patients with moderately to
severely active rheumatoid arthritis who have had an inadequate
response to one or more tumor necrosis factor (TNF) antagonist
therapies. Limitation of Use: Not recommended for use in
combination with other JAK inhibitors, biologic disease-modifying
antirheumatic drugs (DMARDs), or with potent immunosuppressants
such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib)
tablets
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND
THROMBOSIS
SERIOUS INFECTIONS: Patients treated with
Olumiant are at risk for developing serious infections that may
lead to hospitalization or death. Most patients who developed these
infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids. If a serious infection develops,
interrupt Olumiant until the infection is controlled. Reported
infections include:
- Active tuberculosis (TB), which may present with pulmonary
or extrapulmonary disease. Test patients for latent TB before
initiating Olumiant and during therapy. If positive, start
treatment for latent infection prior to Olumiant use.
- Invasive fungal infections, including candidiasis and
pneumocystosis. Patients with invasive fungal infections may
present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic
pathogens.
Carefully consider the risks and benefits of Olumiant prior
to initiating therapy in patients with chronic or recurrent
infection.
Closely monitor patients for the development of signs and
symptoms of infection during and after treatment with Olumiant
including the possible development of TB in patients who tested
negative for latent TB infection prior to initiating
therapy.
MALIGNANCIES: Lymphoma and other malignancies have been
observed in patients treated with Olumiant.
THROMBOSIS: Thrombosis, including deep venous thrombosis
(DVT) and pulmonary embolism (PE), has been observed at an
increased incidence in patients treated with Olumiant compared to
placebo. In addition, there were cases of arterial thrombosis. Many
of these adverse events were serious and some resulted in death.
Patients with symptoms of thrombosis should be promptly
evaluated.
WARNINGS AND PRECAUTIONS
SERIOUS INFECTIONS: The most common serious
infections reported with Olumiant included pneumonia, herpes
zoster, and urinary tract infection. Among opportunistic
infections, tuberculosis, multidermatomal herpes zoster, esophageal
candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis,
cytomegalovirus, and BK virus were reported with Olumiant. Some
patients have presented with disseminated rather than localized
disease, and were often taking concomitant immunosuppressants such
as methotrexate or corticosteroids. Avoid Olumiant in patients with
an active, serious infection, including localized infections.
Consider the risks and benefits of treatment prior to initiating
Olumiant in patients:
- with chronic or recurrent infection
- who have been exposed to TB
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis
or endemic mycoses; or
- with underlying conditions that may predispose them to
infection.
Closely monitor patients for infections during and after
Olumiant treatment. Interrupt Olumiant if a patient develops a
serious infection, an opportunistic infection, or sepsis. Do not
resume Olumiant until the infection is controlled.
Tuberculosis – Before initiating
Olumiant, evaluate and test patients for latent or active
infection and treat patients with latent TB with standard
antimycobacterial therapy. Olumiant should not be given to patients
with active TB. Consider anti-TB therapy prior to initiating
Olumiant in patients with a history of latent or active TB in whom
an adequate course of treatment cannot be confirmed, and for
patients with a negative test for latent TB but who have risk
factors for TB infection. Monitor patients for TB during Olumiant
treatment.
Viral Reactivation – Viral reactivation,
including cases of herpes virus reactivation (e.g., herpes zoster),
were reported in clinical studies with Olumiant. If a patient
develops herpes zoster, interrupt Olumiant treatment until the
episode resolves.
The impact of Olumiant on chronic viral hepatitis reactivation
is unknown. Screen for viral hepatitis in accordance with clinical
guidelines before initiating Olumiant.
MALIGNANCY AND LYMPHOPROLIFERATIVE
DISORDERS: Malignancies were observed in Olumiant
clinical studies. Consider the risks and benefits of Olumiant prior
to initiating therapy in patients with a known malignancy other
than a successfully treated non-melanoma skin cancer (NMSC) or when
considering continuing Olumiant in patients who develop a
malignancy. NMSCs were reported in patients treated with Olumiant.
Periodic skin examination is recommended for patients who are at
increased risk for skin cancer.
THROMBOSIS: Thrombosis, including DVT and PE,
has been observed at an increased incidence in Olumiant-treated
patients compared to placebo. In addition, arterial thrombosis
events in the extremities have been reported in clinical studies
with Olumiant. Many of these adverse events were serious and some
resulted in death. There was no clear relationship between platelet
count elevations and thrombotic events. Use Olumiant with
caution in patients who may be at increased risk of thrombosis. If
clinical features of DVT/PE or arterial thrombosis occur, evaluate
patients promptly and treat appropriately.
GASTROINTESTINAL PERFORATIONS: Gastrointestinal
perforations have been reported in Olumiant clinical studies,
although the role of JAK inhibition in these events is not known.
Use Olumiant with caution in patients who may be at increased
risk for gastrointestinal perforation (e.g., patients with a
history of diverticulitis). Promptly evaluate patients who present
with new onset abdominal symptoms for early identification of
gastrointestinal perforation.
LABORATORY ABNORMALITIES:
Neutropenia – Olumiant treatment was
associated with an increased incidence of neutropenia (absolute
neutrophil count [ANC] <1000 cells/mm3) compared
to placebo. Avoid initiation or interrupt Olumiant treatment in
patients with an ANC <1000 cells/mm3. Evaluate
at baseline and thereafter according to routine patient
management.
Lymphopenia – Absolute lymphocyte count (ALC)
<500 cells/mm3 were reported in Olumiant
clinical trials. Lymphocyte counts less than the lower limit of
normal were associated with infection in patients treated with
Olumiant, but not placebo. Avoid initiation or interrupt Olumiant
treatment in patients with an ALC
<500 cells/mm3. Evaluate at baseline and
thereafter according to routine patient management.
Anemia – Decreases in hemoglobin levels to
<8 g/dL were reported in Olumiant clinical trials. Avoid
initiation or interrupt Olumiant treatment in patients with
hemoglobin <8 g/dL. Evaluate at baseline and thereafter
according to routine patient management.
Liver Enzyme Elevations – Olumiant treatment
was associated with increased incidence of liver enzyme elevation
compared to placebo. Increases of ALT ≥5x upper limit of normal
(ULN) and increases of AST ≥10x ULN were observed in patients in
Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient
management. Promptly investigate the cause of liver enzyme
elevation to identify potential cases of drug-induced liver injury.
If increases in ALT or AST are observed and drug-induced liver
injury is suspected, interrupt Olumiant until this diagnosis is
excluded.
Lipid Elevations – Treatment with Olumiant
was associated with increases in lipid parameters, including total
cholesterol, low-density lipoprotein cholesterol, and high-density
lipoprotein cholesterol. Assess lipid parameters approximately
12 weeks following Olumiant initiation. Manage patients
according to clinical guidelines for the management of
hyperlipidemia.
VACCINATIONS: Avoid use of live vaccines with
Olumiant. Update immunizations in agreement with current
immunization guidelines prior to initiating Olumiant
therapy.
HYPERSENSITIVITY: Reactions such as
angioedema, urticaria, and rash that may reflect drug sensitivity
have been observed in patients receiving Olumiant, including
serious reactions. If a serious hypersensitivity reaction occurs,
promptly discontinue Olumiant while evaluating the potential causes
of the reaction.
ADVERSE REACTIONS
Most common adverse reactions include: upper respiratory tract
infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex
(0.8%, 0.7%), and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and
placebo, respectively.
USE IN SPECIFIC POPULATIONS
PREGNANCY AND LACTATION: No information is available
to support the use of Olumiant in pregnancy or lactation. Advise
women not to breastfeed during treatment with Olumiant.
HEPATIC AND RENAL IMPAIRMENT: Olumiant is not
recommended in patients with severe hepatic impairment or in
patients with severe renal impairment.
Please click to access full Prescribing
Information, including Boxed Warning about Serious infections,
Malignancies, and Thrombosis, and Medication Guide.
BA HCP ISI 09JUL2020
About OLUMIANT®
OLUMIANT, a once-daily,
oral JAK inhibitor was discovered by Incyte and licensed to Lilly.
It is approved in the U.S. and more than 75 countries as a
treatment for adults with moderate to severe rheumatoid arthritis
and is approved in more than 40 countries, including the European
Union and Japan, for the treatment
of adult patients with moderate to severe atopic dermatitis who are
candidates for systemic therapy. OLUMIANT was recently approved in
Japan for the treatment of
pneumonia associated with COVID-19 in hospitalized adult patients.
The U.S. FDA-approved labeling for Olumiant includes a Boxed
Warning for Serious Infections, Malignancy, and Thrombosis. See the
full Prescribing Information here. Baricitinib is also being
investigated in alopecia areata (AA), juvenile idiopathic arthritis
(JIA) and systematic lupus erythematosus (SLE).1
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases.
About Rheumatoid Arthritis
Rheumatoid arthritis is an
autoimmune disease characterized by inflammation and progressive
destruction of joints.2,3 More than 23 million people
worldwide suffer from RA.4 Approximately three times as
many women as men have the disease.5 Patients and
physicians indicate there remains an important opportunity to
improve patient care. Current treatment of RA includes the use of
non-steroidal anti-inflammatory drugs, oral disease-modifying
anti-rheumatic drugs such as methotrexate, and injectable
biological response modifiers that target selected mediators
implicated in the pathogenesis of RA.5
About Lilly in Immunology
Lilly is bringing our
heritage of championing groundbreaking, novel science to immunology
and is driven to change what's possible for people living with
autoimmune diseases. There are still significant unmet needs, as
well as personal and societal costs, for people living with a
variety of autoimmune diseases and our goal is to minimize the
burden of disease. Lilly is investing in leading-edge clinical
approaches across its immunology portfolio in hopes of transforming
the autoimmune disease treatment experience. We've built a deep
pipeline and are focused on advancing cutting edge science to find
new treatments that offer meaningful improvements to support the
people and the communities we serve.
About Eli Lilly and Company
Lilly is a global health
care leader that unites caring with discovery to create medicines
that make life better for people around the world. We were founded
more than a century ago by a man committed to creating high-quality
medicines that meet real needs, and today we remain true to that
mission in all our work. Across the globe, Lilly employees work to
discover and bring life-changing medicines to those who need them,
improve the understanding and management of disease, and give back
to communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at lilly.com and
lilly.com/newsroom.
About Incyte
Incyte is a Wilmington, Delaware-based, global
biopharmaceutical company focused on finding solutions for serious
unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
OLUMIANT® is a registered trademark owned or licensed
by Eli Lilly and Company, its subsidiaries, or affiliates.
P-LLY
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about OLUMIANT (baricitinib) as a treatment for patients with
rheumatoid arthritis and a possible treatment for other conditions
and reflects Lilly's and Incyte's current beliefs and expectations.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of drug research,
development, and commercialization. Among other things, there can
be no guarantee that planned or ongoing studies will be completed
as planned, that future study results will be consistent with the
results to date, and that OLUMIANT will receive additional
regulatory approvals, or be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
and Incyte's most recent respective Form 10-K and Form 10-Q filings
with the United States Securities and Exchange Commission. Except
as required by law, Lilly and Incyte undertake no duty to update
forward-looking statements to reflect events after the date of this
release.
1.
|
Olumiant Prescribing
Information, 2020.
|
2.
|
Klareskog L, Catrina
AI, Paget S. Lancet. 2009;373:659-672.
|
3.
|
Hand Clinics,
Advances in the Medical Treatment of Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed April 23, 2018.
|
4.
|
WHO Global Burden of
Disease Report, (table 7, page 32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
|
5.
|
Hunter TM, et al.
Rheumatol Int. 2017;37:1551–1557.
|
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Refer to:
|
Jen Dial;
dial_jennifer_kay@lilly.com; +1-317-220-1172 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; +1-317-277-1838 (Lilly
investors)
|
|
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
|
|
Christine Chiou;
cchiou@incyte.com; +1-302-274-4773 (Incyte investors)
|
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